Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

FDA Letters Made Public Are Creating New Risks

There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

GUEST COLUMNISTS

Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
The Hidden Operational Cost Contained In Every Small Molecule Portfolio
The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.
Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
How To Implement Post-Approval Changes On A Global Level
To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.
March 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

PHARMA OUTSOURCING WHITE PAPERS

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics
Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

Aggregation In Antibody-Drug Conjugates: Causes And Mitigation
Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
Flexibility In Drug Development: From Tactical Response To Strategic Imperative
Build flexibility into your drug development strategy to navigate change effectively, maintain momentum, and drive successful outcomes across every stage of the lifecycle.
Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies
Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.
Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner
Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.
Biocapacitance Measurement: A PAT Tool For Biomass Measurement In An Upstream Process
Leverage process analytical technologies (PAT) to gain real-time insight into product quality, strengthen control strategies, and build more efficient, scalable manufacturing processes for future success.